(266 days)
The Vilex Redemption Duo Hindfoot Nail System is intended for tibiotalcaneal arthrodesis (fusion)
Specific indications include:
- · Post-traumatic or degenerative arthritis
- · Previously infected arthrosis
- Revision ankle arthrodesis
- Failed total ankle arthroplasty
- · Avascular necrosis of the talus
- · Severe deformity or instability as a result of talipes equinovarus, cerebral vascular accident, paralysis or other neuromuscular disease
- Rheumatoid arthritis
- · Osteoarthritis
- Pseudarthrosis
- · Trauma (malunited tibial pilon fracture)
- · Charcot foot
- · Severe endstage degenerative arthritis
- Severe defects after tumor resection
- Pantalar arthrodesis
- · Post-traumatic arthrosis
- · Neuroarthropathy
The Vilex Redemption Duo system consists of implantable intramedullary nails, endcaps, and locking screws manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136 and PEEK per ASTM F2026) that are implanted into the talocrural region to facilitate tibiotalocalcaneal arthrodesis (fusion). A variety of implant sizes are provided to accommodate individual patient anatomy. The Vilex Redemption Duo system includes device specific instrumentation for use in site preparation, implantation, and removal of the implants and instruments are packaged clean and non-sterile in a sterilization tray with instructions for sterilization prior to surgery.
The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the "Vilex Redemption Duo Hindfoot Nail System." This type of document does not typically contain information about AI/ML device performance, acceptance criteria, or a study specifically designed to demonstrate meeting such criteria as it would for an AI/ML diagnostic or prognostic system.
Instead, this clearance letter is for a physical orthopedic implant system (intramedullary nail) that facilitates tibiotalocalcaneal arthrodesis (fusion). The "performance data" referred to in Section VII relates to mechanical testing of the implant's physical properties, not diagnostic accuracy or AI algorithm performance.
Therefore, I cannot provide the requested information about acceptance criteria, AI/ML device performance, sample sizes, ground truth establishment, or expert involvement, as these concepts are not applicable to the type of device described in this FDA clearance.
The document describes the device's technical characteristics and provides references to the following:
Device Name: Vilex Redemption Duo Hindfoot Nail System
Regulation Number: 21 CFR 888.3020
Regulation Name: Intramedullary fixation rod
Regulatory Class: Class II
Product Code: HSB
Performance Data (Mechanical Testing):
The performance data provided supports the mechanical integrity and safety of the implant, not the performance of an AI algorithm. The tests performed are standard for orthopedic implants and include:
- Bending Fatigue per ASTM F1264-16e1
- Static Torsion per ASTM F543-17
- Driving Torque per ASTM F543-17
- Removal Torque per ASTM F543-17
- Axial Pullout Strength per ASTM F543-17
- Static Four-Point Bending per ASTM F1264-16e1
- Static Torsion per ASTM F1264-16e1
- Dynamic Four-Point Bending per ASTM F1264-16e1
The conclusion states that "Although minor differences in the design exist between the subject and predicate devices, the testing supports that these differences do not raise any different questions of safety and effectiveness. Therefore, it is concluded that the Vilex Redemption Duo Hindfoot Nail System is substantially equivalent to the predicate device." This indicates that the mechanical tests demonstrated equivalent performance to predicate devices, satisfying the FDA's requirements for 510(k) clearance for this type of physical implant.
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.